Central IRB Rosters

[Christina Salinas]

Hello,
I’m looking for guidance on how other companies manage filing central IRB rosters. The Central IRBs we work with provides a copy of the current roster whenever an approval is issued. How do other companies file these rosters? And for all the sites using central IRB?

Also, do you keep them attached to the approval letter or separate the roster and file the roster separately?

Any advice would be appreciated.
Thanks,
Christina

[Christy Nini]

We file the approval and all accompanying documents, including IRB rosters, as a single packet. We file as applicable for the study level and/or site-level, depending on the nature of the submission.

[Janna Gonzalez]

Hi All,

Example of Documents
Confirms an IRB/IEC consists of a reasonable number of members who have the qualifications and experience to evaluate the scientific, medical and ethical aspects of a study.
IRB Membership Roster
(Each IRB Membership listing/roster required during the course of the study)
Original if Local IRB/IEC
A Copy if Central

This document is file Country & Site Level. Zone 04.01.03

Janna

[Author]

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